Merck Reports P-III (KEYNOTE-B15) Trial Finding on Keytruda + Padcev to Treat Muscle-Invasive Bladder Cancer (MIBC)

Shots: The P-III (KEYNOTE-B15/EV-304) trial assessed 4 cycles of Keytruda (IV) + Padcev (IV), followed by surgery & then Keytruda (IV, 13 cycles) plus Padcev (IV, 5 cycles) vs neoadj. SoC + surgery in cisplatin-eligible MIBC pts (n=808) Trial showed that perioperative combination of Keytruda + Padcev significantly improved EFS, OS & pCR rates vs…

ByRidhi RastogiDecember 18, 2025

NEWS

Kyverna Therapeutics Reports Topline P-II (KYSA-8) Trial Data of Miv-cel in Stiff Person Syndrome (SPS)

Shots: Kyverna has reported P-II (KYSA-8) trial data assessing a single dose of mivocabtagene autoleucel (miv-cel; KYV-101) in 26 SPS pts having an inadequate response with non-approved treatment options Trial met its 1EP with 46% median improvement in T25FW & 81% pts achieving a clinically meaningful ≥20% gain, plus significant benefits were seen across all…

ByRidhi RastogiDecember 17, 2025

NEWS

InnoCare Pharma Reports P-IIb Study Findings of Orelabrutinib for Systemic Lupus Erythematosus (SLE)

Shots: Innocare has reported P-IIb trial data assessing orelabrutinib (50 or 75mg, QD, PO) vs PBO in 187 SLE pts for 48wks. & NMPA approval to initiate P-III trial Trial met its 1EP, with 75mg achieving a significantly higher SRI-4 response at Wk. 48 vs PBO (57.1% vs 34.4%) & showing dose-dependent efficacy over 50mg; 75mg…

ByRidhi RastogiDecember 16, 2025

NEWS

Eli Lilly Reports P-III (TRIUMPH-4) Trial Data on Retatrutide for Weight Management

Shots: Trial assessed Lilly’s retatrutide (9 & 12mg) + lifestyle intervention in adults with obesity or overweight & knee osteoarthritis, & without diabetes, meeting its co-1EPs with 26.4% (9mg) & 28.7% (12mg) vs 2.1% weight loss & reduced WOMAC pain by 4.5 & 4.4 vs 2.4 points It also reduced known CV risk markers &…

ByRidhi RastogiDecember 12, 2025

NEWS

Roche Reports P-III (lidERA Breast Cancer) Trial Data on Giredestrant for Early Breast Cancer

Shots: Roche has reported P-III (lidERA Breast Cancer) trial assessing giredestrant (QD) vs SoC endocrine therapy in pts (n=~4,100) with medium or high-risk stage I-III ER+, HER2- breast cancer At the interim analysis, trial met its 1EP of improved invasive disease-free survival (iDFS) by 30%, with 92.4% vs 89.6% pts alive & invasive disease free…

ByRidhi RastogiDecember 11, 2025

NEWS

Eli Lilly Reports P-III (BRUIN CLL-313) Trial Data on Jaypirca for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Shots: Eli Lilly has reported P-III (BRUIN CLL-313) trial data assessing Jaypirca (pirtobrutinib; 200mg, PO, QD; n=141) vs bendamustine + rituximab (n=141) in 282 treatment-naïve CLL/SLL pts without 17p deletions As of Jul 11, 2025, trial met its 1EP of improved IRC-assessed PFS by 80% with benefits seen across all high-risk subgroups & investigator assessments at…

ByRidhi RastogiDecember 10, 2025

NEWS

Incyte Reports Positive P-I Data of INCA033989 in Essential Thrombocythemia (ET) at ASH 2025

Shots: Incyte reported updated data from two P-I trials showing the safety, tolerability, and efficacy of INCA033989 (INCA33989-101 and INCA33989-102) in 455 adults(age≥18) with mutCALR-positive MPNs, including ET & MF, findings were presented at ASH'25 In ET pts receiving higher starting doses of INCA033989 (400–2,500 mg; n=30), 90% achieved a HR, including 83.3% with CHR…

ByDipanshu DixitDecember 9, 2025

NEWS

Nurix Therapeutics Presents New Data from P-I of Bexobrutideg (NX-5948) in Relapsed/Refractory CLL at ASH’25

Shots: Nurix reported updated P-Ia/I b data for bexobrutideg in which P-Ia (n=48) showed an ORR of 83% incl. 2 CRs & a median PFS of 22.1mos. across all doses (50 mg to 600 mg OD) in heavily pretreated relapsed/refractory CLL/SLL pts.; P-Ib data (n=42) indicated higher ORR i.e. 83.3% & longer PFS at the 600mg…

ByPrince GiriDecember 8, 2025

NEWS

CARsgen Therapeutics Presents Trial Data of CT0596 for Relapsed/Refractory Multiple Myeloma (R/R MM) at ASH’25

Shots: CARsgen reported that early clinical results of CT0596, in Pts with R/R MM, were shared in ASH’25. The company plans a P-Ib registrational study in 2026, following an IND submission expected in H2'25 The P-I trial enrolled 8 pts with R/R MM who received CT0596, with a median of 4.5 prior therapy lines. Enrollment…

ByDipanshu DixitDecember 8, 2025

NEWS

Capricor Therapeutics Reports the Topline P-III (HOPE-3) Trial Data on Deramiocel for Duchenne Muscular Dystrophy

Shots: Capricor Therapeutics has reported the topline P-III (HOPE-3) trial data assessing Deramiocel (IV, Q3M) vs PBO in boys & young men (n=106) with DMD for 12mos. across the US Trial met its 1EP with a 54% slowing of upper-limb functional decline (PUL v2.0) among 105 evaluable pts at 12mos. & achieved its 2EP with…

ByRidhi RastogiDecember 4, 2025

Merck Reports P-III (KEYNOTE-B15) Trial Finding on Keytruda + Padcev to Treat Muscle-Invasive Bladder Cancer (MIBC)

Kyverna Therapeutics Reports Topline P-II (KYSA-8) Trial Data of Miv-cel in Stiff Person Syndrome (SPS)

InnoCare Pharma Reports P-IIb Study Findings of Orelabrutinib for Systemic Lupus Erythematosus (SLE)

Eli Lilly Reports P-III (TRIUMPH-4) Trial Data on Retatrutide for Weight Management

Roche Reports P-III (lidERA Breast Cancer) Trial Data on Giredestrant for Early Breast Cancer

Eli Lilly Reports P-III (BRUIN CLL-313) Trial Data on Jaypirca for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Incyte Reports Positive P-I Data of INCA033989 in Essential Thrombocythemia (ET) at ASH 2025

Nurix Therapeutics Presents New Data from P-I of Bexobrutideg (NX-5948) in Relapsed/Refractory CLL at ASH’25

CARsgen Therapeutics Presents Trial Data of CT0596 for Relapsed/Refractory Multiple Myeloma (R/R MM) at ASH’25

Capricor Therapeutics Reports the Topline P-III (HOPE-3) Trial Data on Deramiocel for Duchenne Muscular Dystrophy

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